Actively Recruiting

Phase Not Applicable
Age: 40Years - 60Years
All Genders
Healthy Volunteers
ID06453291

Innovative Approaches in Managing Chronic Low Back Pain: A Comparative Assessment of Clinical Techniques

Led by Iffat Anwar Medical Complex · Updated on 2024-09-04

100

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating different clinical techniques to treat patients with chronic low back pain (CLBP), a condition causing persistent pain for more than three months and affecting quality of life. The study compares conventional therapy using nonsteroidal anti-inflammatory drugs (NSAIDs) and physical therapy with a combination of neuromodulation and platelet-rich plasma (PRP) therapy. The goal is to see if neuromodulation via the dorsal root ganglion and PRP can provide better pain relief and improve function by reducing inflammation and modulating nerve pathways. Participants will be assigned randomly to one of two groups. The conventional therapy group will take NSAIDs daily as prescribed and attend physical therapy sessions twice a week. The neuromodulation plus PRP group will receive weekly neuromodulation sessions via dorsal root ganglion for the first month, followed by monthly maintenance if needed, and weekly PRP injections for the first three weeks. Both treatments involve monitoring and adjustments during the study. Throughout the study, participants will be regularly assessed for pain levels using the Visual Analog Scale (VAS), disability using the Oswestry Disability Index (ODI), and anxiety and depression with the Hospital Anxiety Depression scale (HAD) at multiple time points up to 12 months. Researchers will monitor adherence, side effects, and functional improvements during scheduled visits. The study will last over a year to evaluate both short-term and long-term outcomes for chronic low back pain management.

CONDITIONS

Brief Title

Assessment of Different Clinical Techniques to Treat Patients With Chronic Low Back Pain

Who Can Participate

Age: 40Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40-60 years
  • Diagnosed with chronic low back pain persisting for more than three months
  • Willingness to participate and comply with study procedures
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Presence of comorbidities
  • Contagious and non-contagious infections
  • Known hypersensitivity to study interventions
  • Severe psychiatric disorders
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the last 30 days

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 12 months

Participants receive either conventional therapy, including daily NSAIDs and physical therapy sessions twice a week, or neuromodulation via the dorsal root ganglion combined with platelet-rich plasma (PRP) injections administered once a week for the first three weeks and maintenance neuromodulation sessions monthly if needed.

Physical therapy twice weekly; neuromodulation once weekly for first month, then monthly if needed; PRP injections once weekly for first three weeks

Follow-up

Duration - Up to 12 months

Participants are monitored for pain levels, functional improvement, and any side effects after completing treatment.

Visits at 2 weeks, 3 months, 6 months, and 12 months

Trial Site Locations

Total: 1 location

1

Iffat Anwar Medical Complex

Lahore, Pakistan

Actively Recruiting

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Research Team

S

Shahzad Anwar, MBBS, DOM

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Neurostimulation for the treatment of axial back pain: a review of mechanisms, techniques, outcomes, and future advances.

Timothy Deer, Jason Pope, Salim Hayek...

https://pubmed.ncbi.nlm.nih.gov/25395117